| ObjectiveTo explore the prescription rules of influenza in Lingnan area based on data mining technology,and Subsequently to discover a new prescription,then carry out clinical research to observe its efficacy and safety.MethodsFirst,a prescription database for influenza in Lingnan was established after journal articles online searching;second,multi-level mining methods were conducted to explore the rules of syndrome differentiation,treatment methods and prescription modes,including data statistics,association rule analysis,complex system entropy clustering,and improved mutual information method via the traditional Chinese medicine inheritance auxiliary platform and SPSS 25.0 software;then,a potential new prescription was screened out after the interpretation of the mining results by combining the clinical features and treatment rules of influenza in the region;finally,an open,randomized controlled,single-center clinical trial was conducted to explore the efficacy and safety of the new prescription combined with Oseltamivir in the treatment of influenza,in which 42 eligible participants were randomly divided into the treatment group(n=20),which received oseltamivir capsule plus Lianqin Kanggan granules or the control group(n=22),which received oseltamivir capsule only.Interventions were given for 3 days.During the period,the subjects’ axillary temperature,symptoms and acetaminophen use were followed up,and adverse reactions recorded.Results1.Data mining: A total of 109 target prescriptions were collected,involving 155 Chinese herbs.The main Lesions of influenza in Lingnan is in the surface,lung,spleen and stomach,while the main nature of the pathogen is heat,external wind and moisture.The treatment methods are to clear away heat and detoxify,remove external pathogens by cool and pungent herbs,dehumidify,regulate qi,expectorant,activate the blood to eliminate blood stasis,remove internal and external evils and nourish yin.The prescriptions mainly used includes Yinqiao powder,self-made formulas,Maxingshigan Decoction,Xiaochaihu Decoction and Haoqin Qingdan Decoction.The herbs used to treat influenza in Lingnan are mainly cold,cool and warm in nature,bitter,sweet and pungent in taste,and mainly belong to the lung,stomach,heart,spleen and liver meridians.The most frequently used herbs includes licorice,forsythia,scutellaria,honeysuckle,platycodon,almond,bleu,peppermint,gypsum,burdock seed.The 11 new prescriptions evolved from 22 core combinations mainly have the functions of relieving the surface,clearing away heat,promoting the lungs,clearing the internal organs,reducing dampness,relieving cough and phlegm,replenishing qi and nourishing yin.From the above results,a combination of herbs such as " clearing heat and detoxification","removing external pathogens by cool and pungent herbs",and "eliminating dampness" was selected to form a prescription,named Lianqin Kanggan formula,and a clinical research was conducted subsequently.2.Clinical research: In this study,the TCM prescription was administrated in a granules way,namely Lianqin Kanggan granules.A total of 42 eligible subjects were included and 1 case was lost in the follow-up.Thus,there were 41 subjects(19 in the treatment group vs 22 in the control group)in the per protocol set(PPS)and its efficacy and safety was evaluated.(1)Baseline: There were no significant differences in gender,age,axillary temperature,fever course,influenza virus antigen type,clinical symptoms between the two groups,which indicated that the baseline conditions were comparable.(2)Primary outcome:After treatment,the median time to fever resolution in the treatment group was significantly reduced compared with that of the control group [24.55(17.20)hours vs 27.00(24.85)hours,P<0.05],indicating that Lianqin Kanggan granules combined with oseltamivir capsules can shorten the course of fever.(3)Secondary outcomes:(1)syndrome scores before and after treatment within the group.The median syndrome score of the treatment group was significantly reduced from12(5)points before treatment to 1(2)points after treatment(P<0.001).As for the single symptom score,scores except for expectoration(P>0.05)were significantly reduced after treatment(P<0.05),suggesting that the treatment strategy can significantly alleviate the syndrome and most of the symptoms,but the relief of expectoration was not obvious.The median syndrome score of the control group was significantly reduced from 13.50(5.25)points to 2(2.25)points(P< 0.001);However,as for the single symptom score,scores except for sweating,expectoration,vomiting and nausea and loss of appetite were significant reduced(P<0.05 or 0.01),suggesting that although oseltamivir can alleviate the syndrome and most of the symptoms,it was not effective in relieving sweating,expectoration,vomiting and nausea and loss of appetite.(2)Syndrome scores between groups after treatment.There was a significant difference in the total scores in the treatment group compared to that of the control group [1(2)points vs 2(2.25)points,(P<0.01)].What’s more,single symptom score of the sore throat in the treatment group was significantly reduced compared to that of the control group(P<0.05),and there was no significant difference in other symptom score between the groups(P>0.05),suggesting that the syndrome and the symptom of sore throat in the treatment group were better relieved than that of the control group.(3)Comprehensive efficacy evaluation: According to the evaluation standard,there were 7,11,1,0 and 2,16,3,1 subjects in the experimental group and the control group who were considered to be cured,markedly effective,effective and ineffective after treatment.Significant difference was observed in comprehensive curative effect and recovery rate in the treatment group [P<0.05,(36.84% vs 9.09%)].(4)The amount of acetaminophen used: there was no significant difference between the groups(P>0.05),with 1(2)tablets in the treatment group and 2(2)tablets in the control group.(4)Safety evaluation: No adverse effect was observed during the study period in the control group.However,in the treatment group,a young female subject experienced vomiting and diarrhea for once after taking oseltamivir capsules and Lianqin Kanggan granules,which was considered to be related to the medication or the natural course of the disease.There was no significant difference in adverse events between the two groups(P>0.05).conclusionInfluenza in the Lingnan area is common with wind-heat and dampness syndrome.clearing heat and detoxification,removing external pathogens by cool and pungent herbs are the most commonly used treatment methods.This region still attaches importance to the application of eliminating dampness.Lianqin Kanggan Granules combined with Oseltamivir Capsules in the treatment of simple influenza not only shortens the course of fever,but also shows additional benefits in improving the overall syndrome and sore throat,but cannot reduce the use of acetaminophen.Overall,Lianqin Kanggan Granules are safe.1.Data mining:(1)Influenza syndromes in Lingnan area are mainly manifestations features in lung,spleen,stomach,heat,external wind,and dampness,of which wind-heat and dampness syndrome is a common clinical syndrome;(2)The commonly used treatment methods mainly include clearing away heat and detoxification,pungent cooling and relieving the surface,removing dampness,regulating qi,expectorating,promoting blood circulation and removing blood stasis,removing both the surface and the inside,and nourishing yin;(3)Commonly used prescriptions include Yinqiaosan,self-made prescription,Maxingshigan Decoction,Xiaochaihu Decoction,Haoqin Qingdan Decoction.;(4)High-frequency herbs include licorice,forsythia,scutellaria,honeysuckle,platycodon,almond,bleu,mint,gypsum,burdock;(5)Commonly used herb pairs include scutellaria-forsythia,scutellaria-bupleurum,honeysuckle-forsythia,and forsythia-mint.2.Clinical research part:(1)Lianqin Kanggan Granules plus oseltamivir capsules,or oseltamivir capsules alone are both safe and effective in the treatment of uncomplicated influenza;(2)Lianqin Kanggan Granules plus Oseltamivir Capsules in the treatment of uncomplicated influenza can not only shorten the course of fever,but also show additional benefits in improving the overall syndrome and sore throat,but cannot reduce the effect of acetaminophen.use. |
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